Trinity Biotech Receives WHO Approval For Offshored And Outsourced Upstream Manufacturing Activities Of Uni-Gold HIV Rapid Test

Trinity Biotech plc (NASDAQ:TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its market leading Uni-Gold™ HIV rapid test, a well-established and cornerstone diagnostic product used in HIV screening programs internationally. This regulatory approval marks a further critical milestone in the Company's comprehensive transformation plan aimed at driving sustainable profitability.

This major regulatory approval enables Trinity Biotech to transition upstream production of Uni-Gold™ from its legacy in-house operations to a more cost-effective outsourced model, while maintaining the highest levels of product integrity and regulatory compliance.

The initiative is part of a complex, multifaceted project that has been in development for approximately two years. It reflects the ability of Trinity Biotech's current leadership team to envision and execute high-value, strategic business transformation projects to drive long-term capital value.  This transformation capability creates a long-term value creation driver in the business as it focuses on future growth opportunities.

The transition to outsourced offshore upstream manufacturing is expected to deliver substantial improvements in gross margin, EBITDA and cashflow generation. The move is part of a broader strategic initiative to streamline operations, reduce fixed costs, and focus internal resources on innovation and market expansion.

Trinity Biotech will implement this next phase of this new Uni-Gold™ HIV manufacturing model in the coming months.

Key Highlights:

• WHO approval granted for offshored and outsourced upstream manufacturing activities of Uni-Gold™ HIV.
• Supports transformation plan focused on financial turnaround and sustainable growth.
• Expected to improve gross margins, EBITDA and cashflow generation.